Renewal application for registration of homeopathic medicinal products

Registration holders for homeopathic medicinal products for human use must submit a renewal application at least 9 months before the end of the 5 year registration period, for the application to be valid. For homeopathic medicinal products for animals a renewal application must be submitted at least 6 months before the registration expires.

According to the Swedish Medicines Act [2015:315] 4 chap. 17 §, a registration of a homeopathic medicinal product is valid for 5 years. A registration may be renewed after 5 years on the basis of a re-evaluation. If an application is received too late there is no possibility for the MPA to extend the approval. This means that the approval automatically ceases to be valid when the renewal date has passed and that further sale is forbidden. The MPA has no legal possibilities to give a respite for submission of a renewal application.

Each registered homeopathic medicinal product requires a separate renewal application. The application form can be found on the right hand side under the heading Application form.    

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information